Senior Quality Assurance Specialist - Digital Apps (CVRM)
Core
Senior Quality Assurance Specialist ensuring digital systems compliance and configuration for aseptic drug product manufacturing.
Role type
Senior IC Quality Assurance Specialist (Digital Systems)
Builds
Configured and validated QA digital applications (SAP, Tulip, Speca) for aseptic drug manufacturing.
Domain
Pharmaceutical manufacturing / GxP / Digital Compliance
Required skills
GxP compliance, Computer Systems Validation (CSV), SAP Quality module configuration, Master Data governance, Tulip/Speca/Batch Release Hub administration, Deviation/CAPA management, SOP authoring, Risk assessment, Lean/Six Sigma principles
Preferred skills
Advanced degree in scientific/technical discipline, 6-8 years GxP experience, 3+ years managing QA digital apps, Cross-functional leadership, Change management
Technologies
SAP Quality, Tulip, Speca, Batch Release Hub
Responsibilities
Lead configuration and maintenance of QA-owned digital systems; Execute system testing and CSV activities; Configure SAP workflows and Master Data; Provide QA oversight for custom digital apps; Own deviation investigations and CAPAs; Author and approve SOPs and risk assessments; Drive end-user training programs.
Seniority
Senior, hands-on IC
